A study by Oxford University researchers has found that the antiviral drug TDF may benefit a greater number of patients with chronic hepatitis B virus, and that those who are untreated may be at greater risk of liver inflammation and fibrosis.
The research was carried out under the auspices of the National Institute for Health Research (NIHR) Health Informatics Collaborative (HIC), established in 2014 to make routinely collected clinical data available for translational research in selected therapeutic areas across multiple sites. The NIHR HIC viral hepatitis theme is led by Oxford University Hospitals NHS Foundation Trust and the University of Oxford, through the NIHR Oxford Biomedical Research Centre (BRC).
The paper was published in the open access journal BMC Infectious Diseases.
Current clinical guidelines recommend treating chronic hepatitis B virus (HBV) infection with TDF (tenofovir disoproxil fumarate) in a minority of cases. But until now, there were relatively scarce data on the evolution or progression of liver inflammation and fibrosis in cases of chronic HBV (CHB) that did not meet treatment criteria.
Assessing data from outpatient clinics between 2005 and 2018, the Oxford BRC researchers set out to assess the impact of TDF on liver disease, and the risk of renal impairment in treated CHB patients, compared to patients who did not receive the drug.
The ethnically diverse cohort that was studied included 206 adult patients, 60 on TDF and 146 not receiving the drug.
As expected, viral load and ALT (Alanine transaminase – an enzyme that indicates liver damage when levels are high) declined significantly over time in patients treated with TDF. Elastography scores – an indication of fibrosis – also normalised during treatment.
Some seven per cent of intreated patients had a progression of fibrosis, while the researchers found no evidence of difference in incidence of renal impairment between the two groups.
One of the authors of the paper, Dr Philippa Matthews, Associate Professor at the University of Oxford’s Nuffield Department of Medicine, said: “This study shows the clear benefits of TDF therapy in a diverse CHB population, even among those patients with only mild or moderate liver disease.
“These benefits may be relevant to a wider pool of the untreated CHB population, given the lack of difference in renal impairment observed in the two groups. Larger population studies, over longer periods of follow-up, are urgently needed to provide the evidence to underpin expanded treatment guidelines.”